From recommendation to regulation: Experience of the EU Standing Committee on Plant Health Harmful o

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From recommendation to regulation Experience of
the EU Standing Committee on Plant Health
(Harmful organisms)

• International Plant Health Risk Analysis workshop
  24 - 28 October 2005 Niagara Falls, Canada

• Paul Bartlett
• Plant Health Consultancy Team, Defra-Central
  Science Laboratory, Sand Hutton, York, UK
• Marc Vereecke
• Chair of SCPH, European Commission, Brussels,
  Belgium.
• Francoise Petter
• Deputy DG, European and Mediterranean Plant
  Protection Organisation, Paris, France.

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What is Pest Risk Analysis for?

• To convince decision makers that regulation of a
  pest is justified (or not)
• To give them guidance on suitable, proportionate,
  Phytosanitary Measures
• It is not easy to do.
• Risk assessment better done
• Insufficient on risk management.
• This is an overview of recent European
  experience.

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European experience

• PRA developed over many years,
• Necessary because
• Speed of trade movement
• Large increase in bulk imports of planting
  material
• Too many pests establishing which had not been
  serious in endemic areas
• For example
• Essigs lupin aphid (Macrosiphum albifrons)
• Western flower thrips (Frankliniella
  occidentalis)
• Silver leaf whitefly (Bemisia tabaci)

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Other drivers for change

• Government role for Crop protection changed
• Agreement on initiation of PRA for interceptions
• WTO-SPS agreement of 1994
• The development of EC Single Market

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EC legislation

• Introduced 1976 harmonised standards,
• Member States own import regulations
• 1993 Single Market
• harmonised import regime
• no internal frontiers
• movement with plant passports.

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Structure of EC legislation

• In primary legislation
• Articles main legislation on a Plant Quarantine
  system
• Annexes the Phytosanitary Measures.
• In secondary legislation
• Implementing Directives
• Derogations.

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Structure of EC legislation

• In primary legislation
• Articles main legislation on a Plant Quarantine
  system
• Annexes the Phytosanitary Measures.
• In secondary legislation
• Implementing Directives
• Derogations.

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Annexes of legislation

• I Regulated organisms
• II - Regulated organisms associated with host
• III Prohibitions
• IV Phytosanitary Measures
• V Certificate requirements.

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How is this done in Europe

• Member State/ Country

EC
EPPO
WTO- SPS IPPC
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Role of EPPO in Pest listing

• 47 Member Governments
• Alerted to new risk developing
• Alert list (a summary datasheet)
• Why alert
• Where is it found
• On what hosts
• Damage
• Dissemination
• Pathway
• Possible risks
• Sources of information.

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EPPOs role in PRA

• Specialist Panels may develop PRA
• Phytosanitary Measures Panel harmonises these
• Approved by the Phytosanitary Regulations
  Working Party and EPPO Council
• Standardised implementation
• PR Assessment scheme (EPPO, 1997 EPPO, 2002)
• More recently PR Management scheme been
  developed
• Forces consideration of each potential pathway
  (EPPO, 2001).
• From 2006 a newly established Panel will conduct
  PRAs (as Suffert Petter Monday).
• Action List Member Governments consider for
  regulation.

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EC regulations

• EC is smaller, less diverse than EPPO
• The European Commission considers the EPPO
  recommendations EC specific evidence
• Proposes pest listing and accompanying
  phytosanitary measures to the SCPH.
• European Food Standards Agency (EFSA) role in
  considering the recommendations of the PRA to be
  developed.

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How is this done in the EU?

• Working Groups of experts assist the European
  Commission to develop proposals for regulation
• This includes selection of recommendations for
  phytosanitary measures
• Then report their recommendations to SCPH, the
  decision makers
• Following revision in plenary sessions, a
  regulation may be agreed and adopted.

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Emerging processes in the EC EC Annexes Working
Group

• Since 2003, an EC Annexes Working Group of
  experts has been examining proposals for pest
  specific regulation
• examine recommendations from EPPO and other
  Member States
• a single WG means there will be greater
  uniformity of evaluation of the proposals
• difficulties, requires experts that have
  considerable breadth of knowledge
• all pest organisms from viroids to invasive
  plants considered
• the risk to many diverse crops husbanded in
  different ways
• different environments, both natural and man
  made.

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Choice of Phytosanitary Measures

• Consider many different possible measures
• required for all imports and
• may also be required for movements within the EC
  (controlled by the plant passport)

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Choice of Phytosanitary Measures

• selection of measures determined by statutory
  requirements, custom and practice
• Prohibition and post-entry quarantine not usually
  acceptable
• Treatments not to restrict what may be used
• recognition that pesticide registrations differ
  worldwide and
• facilities for physical treatments are not
  universally available.
• Recognise smallest justified pest free export
  areas for the organism
• Exceptionally area freedoms only recognised by
  surveillance according to EC legislation.

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How to deliver to the Standing Committee on
Plant Health?

• Considerable, diverse information gathered from
  different sources and evaluated
• Must be made available to the SCPH
• An outline electronic proforma has been devised
  to facilitate this
• the Annexes Working Group Recommendations
• Attaches supporting documentation
• eases the work of the SCPH
• also provides a transparent justification for the
  proposals.

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Annexes Working Group RecommendationsThe
Proforma Part 1

• Harmful organism name
• with Bayer code if known details of
  taxonomic position
• Present regulatory status in the EC legislation
• Information on Harmful organism, hosts present
  pest status in the European Union

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Annexes Working Group Recommendations The
Proforma Part 2

• The Working Group recommends that the Standing
  Committee on Plant Health should consider
  amending the relevant Annexes to the Directive
  2000/29/EC as follows
• recommendation
  inserted
• Recommendation for listing Annex I or Annex II
• Recommendation for Phytosanitary Measures Annex
  IV A I, IV A II or IVB
• Recommendations for requirements for
  Phytosanitary Certificates and / or plant
  passports Annexes VA and VB
• Explanation of Recommendation

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Annexes Working Group Recommendations The
Proforma Part 3

• Justifying supporting documentation. Ø     
  Quarantine pests for Europe (1997) Data sheet.
  Ø      Pest Risk assessment EPPO or
  otherØ      Report of a Pest Risk Assessment
  EPPO or other Ø      Pest Risk Management and or
  Pest Specific Phytosanitary Regulations
  EPPOØ      Report of a PRM/PSPRØ      EPPO
  published Diagnostic protocolØ      EPPO
  Phytosanitary ProceduresØ      EPPO Alert
  Ø      Report of discussions at Annexes Working
  GroupsØ      Report of discussions at EPPO or
  other meetings.
• Others letters, legislation etc.

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Progress

• New, and evolving process
• In late 2004 first recommendations prepared for
  submission to the SCPH
• 22 recommendations presented at the March and
  April 2005 committees

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Recommendations

• Aonidiella citrina
• Apple proliferation mycoplasm
• Cacopsylla fulguralis
• Chrysanthemum Stem Necrosis Virus
• Ciborinia camelliae
• Dendrolimus sibiricus
• Diabrotica virgifera
• D. v. virgifera
• D. v. zeae
• Dryocosmus kuriphilus
• Fusarium foetens
• Impatiens necrotic spot virus

• Leveillula taurica
• Monilinia fructicola
• Parasaissetia nigra
• Paysandisia archon
• Rhynchophorus ferrugineus
• Rhynchophorus palmarum
• Scrobipalpopsis (Tecia) solanivora
• Stegophora ulmea
• Thrips australis
• Xanthomonas axonopodis pv. Dieffenbachiae

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Progress

• The recommendations varied. For example-
• simple, that no regulation was justified
• to transfer the pest between annexes (as
  recognition pest now established in part of the
  EU) with additional Measures certified by plant
  passports
• New listings with additional phytosanitary
  certificates and associated measures required.
• Now with the European Commission and the first
  proposals are emerging for SCPH

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Recording uncertainty

• Developing this process has highlighted some
  difficulties with using information,
  recommendations and ISPMs
• Especially ensuring the risk management options
  are appropriate and proportionate
• Important to ensure that data sheets and risk
  assessments record
• when there is a lack of information or
• when it is known that something does not happen.
• The EPPO PRA scheme emphasises the first and
  indicate when further research is needed

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Risk Managers needs known unknowns and known
nos!

• Guidance when negative information is known
• Pathway analysis is the key to selecting
  Phytosanitary Measures
• When a pathway cannot or does not exist, this
  must be recorded. NOT goes without saying
• For example, that the fruit of a virus infected
  plant may never be infected.
• an organism may not be truly seed-borne but, can
  it contaminate a seed?
• If omitted an uncertainty may result in
  recommending unsuitable Measures.

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Risk Managers needs Economic evaluation - crop
husbandry

• Also required in the assessment report is an
  evaluation of the husbandry of crops
• Can be relatively straightforward

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Tomato evaluation

• an important crop throughout the EU
• crop area and value is recorded
• tomato pests unlikely to have environmental
  consequences
• BUT risks and cost-benefit analysis different
  between
• outdoor grown
• lightly protected crops of the south
• glasshouse, heated, crops of
• the north.

Pepino mosaic virus
Liriomyza huidobrensis
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Maize (Zea mays) evaluation

• More complex example.
• very different values and uses in Europe.
• when used for animal feed, may be
• fed whole cob
• whole plants finely chopped
• off cob as grain maize
• or as direct pasture feed.
• for human consumption may be
• off or on the cob
• with very strictly controlled inputs for baby
  food.

• also planting and harvesting times vary - this
  affects the biology, and thus the risk, of most
  pest organisms.

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Tree evaluation

• Evaluation more complex when plant has both
  amenity and environmental uses,
• For example trees.

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• Horse chestnut (Aesculus hippocastanum)
• an amenity tree,
• of considerable benefit in streets and parks.

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Sweet chestnut(Castanea spp.)

• timber,
• coppice,
• fruit bearing,
• amenity.

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Other consideration for the Risk Manager

• Considerable variation in economic, environmental
  and social risks may occur throughout 25 Member
  states
• A key challenge in developing PRAs valid for the
  whole EU.
• These examples all illustrate the difficulties of
  conducting PRA for an enlarging EU, as discussed
  by Baker (on Tuesday).

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Completing the Loop

• In Europe has been recognised that these
  experiences are fed back into the Risk Analysis
  process
• Therefore the development of the EPPO Risk
  Assessment and Risk Management procedures is
  dynamic (as explained by Muriel Suffert on
  Monday).

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Finalising the decision

• Completion of a report on the PR Analysis is not
  finalisation.
• A formal consultation process about the PRA which
  actively involves advisors, growers and
  administrators is then invoked
• Before new regulations agreed an analysis of
  costs and benefits presented as a regulatory
  impact assessment.
• When impact high, RIA can be detailed with
  several scenarios to be evaluated (MacLeod on
  Tuesday).
• If cost of measures to government, importers or
  exporters, disproportionate to the risk, then
  SCPH can ask whether a less demanding Phyto
  measure will provide adequate safeguarding.

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Final difficulties

• Broadening of consultation hampered by
• need for swift introduction of justified
  regulations and
• the diminishing number of specialists available
  to provide the independent analysis that
  recommendations demand.
• Introduction of specialised and practical ISPMs
  may help, but only if they permit sufficient
  flexibility of implementation and they address
  the priority organisms.

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Regulated Non-Quarantine Pests

• Not considered in this paper
• Have begun consideration by both EPPO and the EC
• Actively gathering information on Regulated pests
  already present in EU
• Not hide that linkage to PfP is causing
  considerable difficulties.

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EC Legislation

• Development introduction of legislation is a
  transparent process
• Follows the WTO-SPS procedures
• Also new regulations, minutes of the SCPH and
  legislation all available via the Internet.
  http//europa.eu.int/comm/food/plant/index_en.htm.
  

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Conclusions

• A work in progress
• The process both within EPPO and at EC SCPH
  evolves
• Number of organisms already in-train is
  daunting
• EPPO has either-
• approved for the Action list
• on the Alert List or
• at in-between stages.
• Others in EC
• limited derogations
• subjects of new emergency action.

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Acknowledgements

• Many colleagues located in diverse parts of
  Europe are responsible for PRAs, PRMs and their
  evaluation.
• The membership of EPPO Panels is on their
  website.
• The considerable assistance of the expert members
  of the EC Annexes WG,
• Ingrid Akesson (Sweden), Hanna Baginska
  (Poland)
• Franco Finelli (Italy), Lieven van Herzele
  (Belgium)
• Michal Hnizdl (Czech Rep), Nico Horn
  (Netherlands),
• Vlasta KnapiC (Slovenia), Claira Pacheco
  (France),
• Consuelo Perez (Spain), Gritta Schrader
  (Germany).